ORALBRCHGTOOTHBRUSHHANDLE3769IOSRSG3

Additional Manufacturer Narrative

PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.

Description of Event or Problem

ELECTRICAL FIRE IN MY THROAT - ORAL-B ELECTRIC TOOTHBRUSH [THERMAL BURN] THROWING UP BLOOD [HAEMATEMESIS] MY TOOTHBRUSH LITERALLY CAUGHT FIRE AND STARTED A SMALL ELECTRICAL FIRE IN MY THROAT - ORAL-B [DEVICE PHYSICAL PROPERTY ISSUE] CASE NARRATIVE: THE CONSUMER, UNSPECIFIED AGE AND GENDER, REPORTED SPONTANEOUSLY VIA SOCIAL MEDIA ON (B)(6) 2023 THAT THEY USED ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3769 IO SERIES G3 (BATCH/LOT: AN23612108) AND ORAL-B POWER ORAL CARE REFILLS, BEGINNING IN 2023 (ABOUT 6 MONTHS AGO), AND THE TOOTHBRUSH CAUGHT FIRE (2023). THEY DESCRIBED THAT THE FIRE STARTED A SMALL ELECTRICAL FIRE IN THEIR THROAT THAT CAUSED THEM TO THROW UP BLOOD (2023). THE CONSUMER WENT TO THE EMERGENCY ROOM. TREATMENT DETAILS: UNKNOWN. DEVICES USED PREVIOUSLY: UNKNOWN. RELEVANT HISTORY: NONE REPORTED. CONCOMITANT PRODUCT(S): NONE REPORTED. THE EVENT AND CASE OUTCOMES WERE UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. 12-JAN-2024 RECEIVED FOLLOW UP VIA SOCIAL MEDIA: THE CONSUMER REPORTED ADDITIONAL TREATMENT DETAILS: SURGERY ON THROAT FROM THE DISCHARGE OF THE TOOTHBRUSH. THE CASE OUTCOME REMAINED UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. CASE UPDATE FROM 12-JAN-2024: THE SUSPECT PRODUCT, ORAL-B POWER ORAL CARE REFILLS, WAS CHANGED TO A CONCOMITANT PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

Description of Event or Problem

TORE ESOPHAGUS/MALLORY-WEISS TEAR [MALLORY-WEISS SYNDROME]. ELECTRICAL FIRE IN MY THROAT - ORAL-B ELECTRIC TOOTHBRUSH [THERMAL BURN]. THROWING UP BLOOD [HAEMATEMESIS] . TOOTHBRUSH LITERALLY CAUGHT FIRE AND STARTED A SMALL ELECTRICAL FIRE IN MY THROAT/TOOTHBRUSH BACKFIRED AND SHOT SPARKS INTO THROAT - ORAL-B [DEVICE PHYSICAL PROPERTY ISSUE]. CASE NARRATIVE: THE CONSUMER, UNSPECIFIED AGE AND GENDER, REPORTED SPONTANEOUSLY VIA SOCIAL MEDIA ON 28-DEC-2023 THAT THEY USED ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3769 IO SERIES G3 (BATCH/LOT: AN23612108) AND ORAL-B POWER POWER ORAL CARE REFILLS, BEGINNING IN 2023 (ABOUT 6 MONTHS AGO), AND THE TOOTHBRUSH CAUGHT FIRE (2023). THEY DESCRIBED THAT THE FIRE STARTED A SMALL ELECTRICAL FIRE IN THEIR THROAT THAT CAUSED THEM TO THROW UP BLOOD (2023). THE CONSUMER WENT TO THE EMERGENCY ROOM. TREATMENT DETAILS: UNKNOWN. DEVICES USED PREVIOUSLY: UNKNOWN. RELEVANT HISTORY: NONE REPORTED. CONCOMITANT PRODUCT(S): NONE REPORTED. THE EVENT AND CASE OUTCOMES WERE UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. 12-JAN-2024 RECEIVED FOLLOW UP VIA SOCIAL MEDIA: THE CONSUMER REPORTED ADDITIONAL TREATMENT DETAILS: SURGERY ON THROAT FROM THE DISCHARGE OF THE TOOTHBRUSH. THE CASE OUTCOME REMAINED UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. CASE UPDATE FROM 12-JAN-2024: THE SUSPECT PRODUCT, ORAL-B POWER POWER ORAL CARE REFILLS, WAS CHANGED TO A CONCOMITANT PRODUCT. NO FURTHER INFORMATION WAS PROVIDED. 05-FEB-2024 PRODUCT UPDATE FROM INITIAL CONTACT ON 28-DEC-2023: THE CONCOMITANT PRODUCT WAS UPDATED TO ORAL-B POWER ORAL CARE REFILLS IO SERIES. NO FURTHER INFORMATION WAS PROVIDED. 08-APR-2024 RECEIVED PRODUCT EXPERIENCE QUESTIONNAIRE: THE CONSUMER, AN ADULT MALE, USED THE TOOTHBRUSH 100 TIMES TO BRUSH TEETH, BEGINNING IN (B)(6) 2023. THE PRODUCT WAS USED FOR 3-4 MONTHS BEFORE THE PRODUCT OCCURRED. THE PROBLEM IN HIS THROAT BEGAN IN (B)(6) 2023. THE CONSUMER WAS BRUSHING HIS TEETH WHEN THE TOOTHBRUSH BACKFIRED AND SHOT SPARKS INTO HIS THROAT ((B)(6) 2023) AND TORE HIS ESOPHAGUS ((B)(6) 2023). HE WENT TO AN URGENT CARE FACILITY AND AN EMERGENCY ROOM ((B)(6) 2024). HE PREVIOUSLY USED THE EXACT PRODUCT(S) BEFORE (IN 2022, EVERYDAY) WITHOUT A PROBLEM. THE CONSUMER STOPPED USING THE PRODUCT. HE HAD NOT EXPERIENCED THIS PROBLEM OR A SIMILAR PROBLEM IN THE PAST. PAST MEDICAL CONDITIONS: NONE. AN UNSPECIFIED TYPE OF TOOTHBRUSH WAS PREVIOUSLY USED FOR THIS PURPOSE. ALLERGIES: NONE. WEIGHT: 195 POUNDS. HEIGHT: 75 INCHES. THE EVENT OUTCOMES WERE UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. 08-APR-2024 RECEIVED MEDICAL RECORD: A PHYSICIAN REPORTED THAT THE PATIENT UNDERWENT AN UPPER GASTROINTESTINAL TRACT ENDOSCOPY ON (B)(6) 2024, WITH THE FOLLOWING FINDINGS: A MALLORY-WEISS TEAR, A NORMAL EXAMINED DUODENUM, AND A NORMAL STOMACH. THE MALLORY-WEISS TEAR WAS HEALING. TREATMENT DETAILS: UNSPECIFIED MEDICATIONS, INTRAVENOUS (IV) MEDICATION(S), THROAT LOZENGES, GARGLE WITH WARM SALT WATER, AND APPLY WARM MOIST TOWEL TO (IV SITE) AREA. HE WAS DISCHARGED HOME. EVENT OUTCOMES: ELECTRICAL FIRE IN MY THROAT - ORAL-B ELECTRIC TOOTHBRUSH, THROWING UP BLOOD - UNKNOWN, AND TORE ESOPHAGUS/MALLORY-WEISS TEAR - IMPROVED. THE CASE OUTCOME WAS IMPROVED. NO FURTHER INFORMATION WAS PROVIDED. 17-MAY-2024 RECEIVED INVESTIGATION RESULTS: CONCLUSION CODE FOR ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3769 IO SERIES G3: OTHER. THE CONCLUSION CODE 'OTHER' WAS CHOSEN AS IT COVERS MULTIPLE CONCLUSION CODES, INCLUDING 'NO MANUFACTURING CAUSE' AND 'NO DESIGN ISSUE' IDENTIFIED BASED ON INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

17-MAY-2024 PRODUCT INVESTIGATION RESULTS: PRODUCT RETURN WAS RECEIVED AND EVALUATED. NO FAILURE COULD BE IDENTIFIED, THE PRODUCT IS ACCORDING TO SPECIFICATIONS.